MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number CVD0091

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 20mm amplatzer septal occluder was implanted.The device was used to close a defect ballooned sized to 20.2mm by fluoroscopy and 18mm by echo with a 25mm pts sizing balloon.The site initially attempted closure with a 30mm gore cardioform occluder, but the device did not sit well and was exchanged for the 20mm septal occluder.On (b)(6) 2019, the patient presented at the emergency room with chest pain and a pericardial effusion was verified by echo.The patient was taken into surgery for device removal and patch repair via an open sternotomy.The surgeon identified a perforation in the roof of the left atrium in the area of the superior rim and a hematoma in the pericardial space.The surgery was completed without further complication.On (b)(6) 2019, the patient was discharged from the hospital.

Manufacturer Narrative

An event of pericardial effusion, device removal, a perforation in the area of the superior rim, and a hematoma in the pericardial space was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9081639
• MDR Text Key: 162951611
• Report Number: 2135147-2019-00269
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CVD0091
• Device Lot Number: 5175835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 62